In response to the FDA’s draft guidance on Expedited Programs for Serious Conditions, Representatives Gus Bilirakis (R-FL), GK Butterfield (D-NC), Ileana Ros-Lehtinen (R-FL), and Jim Moran (D-VA) are circulating a bipartisan letter in Congress calling on the FDA ensure the final guidance fully implements FDASIA to give rare diseases access to Accelerated Approval. Because of the support of the patient community 24 Members of Congress have signed onto the letter.
RareVoice Award nominations are open to the public. We encourage the community to nominate individuals and organizations who advocate for legislation and policy that benefits the rare disease community. Deadline to submit nominations is Friday August 23, 2103.
Join Global Genes Project for their 2nd Annual “RARE Patient Advocacy Summit” to be held on Friday, September 20, 2013 at The Balboa Bay Club & Resort in Newport Beach, CA. Register today! Seating is limited for in-person participation. Webcast registration available for those unable to attend in person.
US Conference on Rare Diseases & Orphan Products: The New Era in Health Care, which will be held October 7-9 in North Bethesda, MD.
This year, the third Annual Meeting of stakeholders in the rare disease/orphan product community comes at an opportune time. Two new laws – the Affordable Care Act (ACA) and the FDA Safety and Innovation Act (FDASIA) – are being implemented.
Coalition Letter: Health Information Technology Framework
Proper oversight of health IT is critical to ensuring patient safety, however such oversight must be implemented in a balanced way that also fosters innovation and encourages adoption of these technologies. A coalition is encouraging the Administration to ensure health IT is regulated in a way that achieves the goals of improving the quality, safety and cost-effectiveness of care.
Read the letter & see the long list of supporters here: Coalition Sign-on Letter Regarding Policy Associated with Health IT. To add your organization to the growing list of supporters, please contact Jen Bernstein at firstname.lastname@example.org.
FASEB ACTION ALERT: The Senate Appropriations Committee is expected to consider the Labor, Health and Human Services (LHHS) bill that will provide fiscal year (FY) 2014 funding for the National Institutes of Health (NIH). Although we don’t know when the House Appropriations Committee will vote on NIH funding, the spending limits in the House Budget Resolution could mean another 18 percent cut for biomedical research – below sequestration! NIH needs $32 billion in FY 2014 to prevent further erosion of the nation’s capacity for biomedical research and provide funding for additional grantees.
When it comes to approving new medical treatments, the Food and Drug Administration is balancing the need for patient safety against the urgency of making important new available as quickly as possible.
Obama Care Implementation: Sign on to Ensure Rare Diseases Patients have access to needed treatments, physicians and specialists in new Health Insurance Exchanges
Deadline to sign on is COB Friday, May 31st.
An informal coalition is working with the American Life Sciences Innovation Council (ALSIC) to protect Medicare Part B against cuts, especially for injectables or drugs administered by physicians for cancer, arthritis, rare diseases and other conditions.